Individually sealed antiseptic applicators

ABSTRACT

This disclosure describes example applicators and cap devices which may be used in combination with one or more cleansing, antimicrobial and/or antiseptic agents to reduce or eliminate contaminates on a surface. According to some embodiments, the disclosure describes a first cap which may be stored within a cavity of a second cap to create a dual cap device. According to some embodiments, both caps of the dual cap device may be individually sealed with a protective film. According to some embodiments, either a single cap device or a dual cap device may be attached to a flexible substrate by a surface other than the surface having the cavity opening.

CROSS REFERENCE TO RELATED APPLICATION

This Application claims priority to and is a continuation of U.S. patentapplication Ser. No. 14/588,229, filed Dec. 31, 2014, which isincorporated herein by reference.

BACKGROUND

Healthcare acquired infection (HAI) has been recognized as a significantcause of preventable mortality and morbidity. In some instances, HAIsmay be acquired by the introduction of microorganisms into anintravenous (IV) line, such as a peripheral IV line and central IV line.For instance, microorganisms present on a surface of an injection portof the IV line may be introduced into a patient during the preparationor initiation of fluid administration into or withdrawal from the IVline. Accordingly, it may be advantageous to develop methods and devicesfor cleaning of external surfaces of IV access ports and/or internalport areas to reduce risks of microorganism colonization and infection.In addition, it may be advantageous to develop methods and devices forcapping the external surfaces of IV access ports and/or internal portareas to reduce risks of microorganism colonization and infection.

BRIEF DESCRIPTION OF THE DRAWINGS

The detailed description is set forth with reference to the accompanyingfigures. In the figures, the left-most digit(s) of a reference numberidentifies the figure in which the reference number first appears. Theuse of the same reference numbers in different figures indicates similaror identical items or features.

FIGS. 1-4 illustrate example applicators and cap devices which may beused in a single cap device or a dual cap device.

FIGS. 5-7 illustrate example embodiments of individually sealedapplicators and cap devices used in dual cap devices.

FIG. 8 illustrates an example configuration and packaging ofindividually sealed single cap devices and/or dual cap devices.

FIG. 9 illustrates an example embodiment of individually sealedapplicators and cap devices used in dual cap devices and a configurationand packaging of such.

DETAILED DESCRIPTION

Overview

This disclosure describes medical applicators and protective cap devicesdesigned to reduce and/or prevent infections. In one embodiment, thedisclosure describes individually sealed applicators and cap devices. Inother embodiments, the disclosure describes dual cap devices comprisingthe individually sealed applicators and cap devices. The individuallysealed applicators and cap devices may include a permeable foamapplicator material that may be coated or filled with, for example, acleansing, antiseptic or antimicrobial composition. In some embodiments,an open end of each individually sealed applicator and cap device may besealed with a removable protective film or cover to maintain theapplicator material and cleansing, antimicrobial, or antisepticcomposition in the respective caps. In some embodiments, a surface otherthan the open end (i.e. a top end) of individually sealed applicatorsand cap devices or dual cap devices may be consecutively adhered orbonded directly to a substrate such as, for example, a tape or strip.

In other embodiments, the disclosure describes applicators and capdevices which may include an external cap device configured to hold orstore an internal cap device within a cavity of the external cap device.In some embodiments, the each applicator or cap device may beindividually sealed. In other embodiments, only the external cap devicemay be sealed over the open end with a removable protective film orcover to maintain the internal cap device, an applicator material and/orcleansing, antimicrobial, or antiseptic composition in the respectivecap devices. In some embodiments, a surface other than the open end ofexternal cap device may be coupled or bonded directly to a substratesuch as, for example, a tape or strip with a plurality of other capdevices. For example, a top end of each cap device may be consecutivelyadhered to a roll-able strip.

This overview, including section titles, is provided to introduce aselection of concepts in a simplified form that are further describedbelow. The overview is provided for the reader's convenience and is notintended to limit the scope of the claims, nor the proceeding sections.

Example Composition

In one example embodiment, antimicrobial or antiseptic compositions thatmay be used in connection with the approaches described herein mayinclude those described in, for example, U.S. Provisional PatentApplication No. 61/412,375, filed Nov. 10, 2010 to Tennican et al.,which is incorporated herein by reference. For example, theantimicrobial compositions may include water (H₂O), a strong andnon-toxic chelating agent such as ethylenediaminetetraacetic acid(EDTA)(e.g., disodium EDTA, calcium disodium EDTA, magnesium EDTA,potassium EDTA, gallium EDTA) or sodium citrate (or acids, salts,derivatives, or other forms of EDTA or sodium citrate), a short-chainmonohydric alcohol (e.g., ethanol with a molecular formula of C₂H₅OH andan empirical formula of C₂H₆O), and a strong, small molecule oxidizingagent such as hydrogen peroxide (H₂O₂). In one specific example, thecompositions may consist essentially of water, EDTA, ethanol, andhydrogen peroxide. Additional ingredients can include thickeners,gellants (e.g., hydroxypropyl methylcellulose (HPMC), carboxymethylcellulose (CMC), methyl cellulose, methyl hydroxyethyl cellulose (MHEC),hydroxyethyl cellulose, sodium hydroxyalkyl cellulose, dimethicone,silicone gel, or combinations thereof), surfactants, foamers and/or foamstabilizers. However, in other examples, other antimicrobialcompositions may be used in combination with the applicators and devicesdescribed in this disclosure.

In some embodiments, the antimicrobial composition may include fromwater; from about 20% to about 70% by volume of ethanol; from about 0.5%to about 7.5% by volume of hydrogen peroxide; from about 5 mg/mL toabout 50 mg/mL of ethylenediamine tetraacetic acid (EDTA), acids ofEDTA, salts of EDTA, citrate, salts of citrate or any combinationthereof.

The antimicrobial compositions may be in a liquid form or a gel form,and may be combined with one or more carriers or diluents, depending onthe needs of a specific application. For example, if the antimicrobialcomposition is used as a cleaning agent the antimicrobial compositionmay be in a liquid form. In that case, the concentration of the variousconstituents may depend on, for example, a desired level of sanitationand/or disinfection, whether the composition is being applied directlyto living tissue or to a medical device, and/or avoidance of irritationof tissue to which the composition will be applied directly orindirectly (e.g., via a medical device to which the composition is orwas applied).

In addition to providing disinfection at the time of the application,the antimicrobial compositions may also provide a lasting barrieragainst contamination. For example, even after volatile constituents ofthe composition (e.g., water, alcohol, hydrogen peroxide, etc.) haveevaporated, the chelating agent may remain on the treated surfaces(e.g., multiple use vial or port cleaning/protecting device,stethoscope, fingers, surrounding tissue, etc.) as a barrier that willprovide antibacterial, antifungal or sporicidal (e.g., preventinggermination of the spores), anti-parasitic, spermicidal or spermiostatic(e.g., decrease the motility of spermatozoon) and antiviral qualities.By robbing the environment of components (e.g., iron, magnesium, andmanganese) that are needed for the bacteria, spores, parasites, fungusand viruses to reproduce, the chelating agent may provide a lastingdefense to contamination even after other constituents of theantimicrobial composition have evaporated. Furthermore, the hydrogenperoxide in the antimicrobial compositions may induce a charge on asurface of materials (e.g., silicone materials) to which theantimicrobial compositions are applied, which make the materials moreresistant to bacteria or other microorganisms.

In some embodiments, the antimicrobial composition described above mayalso provide a visual indication of contamination when applied to asurface or material, such indication may allow users to identify andclean surfaces to prevent infection.

The term “about” or “approximate” as used in context of describing theexample antimicrobial composition is to be construed to include areasonable margin of error that would be acceptable and/or known in theart.

As used herein, the terms “a,” “an,” and “the” mean one or more.

As used herein, the terms “comprising,” “comprises,” and “comprise” areopen-ended transition terms used to transition from a subject recitedbefore the term to one or more elements recited after the term, wherethe element or elements listed after the transition term are notnecessarily the only elements that make up the subject.

As used herein, the terms “having,” “has,” “contain,” “including,”“includes,” “include,” and “have” have the same open-ended meaning as“comprising,” “comprises,” and “comprise” provided above.

The present description may use numerical ranges to quantify certainparameters relating to the invention. It should be understood that whennumerical ranges are provided, such ranges are to be construed asproviding literal support for claim limitations that only recite thelower value of the range as well as claim limitations that only recitethe upper value of the range. For example, a disclosed numerical rangeof 10 to 100 provides literal support for a claim reciting “greater than10” (with no upper bounds) and a claim reciting “less than 100” (with nolower bounds) and provided literal support for and includes the endpoints of 10 and 100.

The present description may use specific numerical values to quantifycertain parameters relating to the invention, where the specificnumerical values are not expressly part of a numerical range. It shouldbe understood that each specific numerical value provided herein is tobe construed as providing literal support for a broad, intermediate, andnarrow range. The broad range associated with each specific numericalvalue is the numerical value plus and minus 60 percent of the numericalvalue, rounded to two significant digits. The intermediate rangeassociated with each specific numerical value is the numerical valueplus and minus 30 percent of the numerical value, rounded to twosignificant digits. The narrow range associated with each specificnumerical value is the numerical value plus and minus 15 percent of thenumerical value, rounded to two significant digits. These broad,intermediate, and narrow numerical ranges should be applied not only tothe specific values, but should also be applied to differences betweenthese specific values.

Example Applicators and Cap Devices

In some embodiments, the example applicators and cap devices may beconfigured to secure to medical instruments and/or laboratory equipment.For example, the example applicators and cap devices may be configuredto connect to a syringe with a male or female LUER-LOK® connectionfitting, a slip tip LUER-SLIP® fitting, a central or peripheral IV port,a catheter port (i.e., a peripherally inserted central catheter of acentral venous catheter), PORT-A-CATH®, multi-dose vials, among others.While FIGS. 1-4 illustrate the example applicators and cap devices ashaving a generally round shape, alternative shapes are contemplated suchas, for example, a square shape, a rectangular shape, an oval shape, apolygon shape, and the like. In addition, example applicators and capdevices may be manufactured in any size to accommodate the various sizesof the ports or connectors to which the applicators and cap devices maybe attached

Example materials for the composition of the example applicators and capdevices include, but are not limited to, polypropylene, polyethyleneand/or other copolymer materials. The example applicators and capdevices may also comprise a material or agent that is UV protective topreserve the integrity of a composition, such as one described in thepreceding section, during storage, shipping, etc. In other embodiments,the example applicators and cap devices may comprise caps such as thosedescribed in U.S. patent application Ser. No. 13/688,044, filed Nov. 28,2012 to Tennican et al., entitled “Port and Surface Cleaning Devices andTechniques,” which is incorporated herein by reference.

FIG. 1 illustrates a first example cap device 100. As shown in FIG. 1,the inner surface of the example cap device 100 includes threads 102molded into the inner surface of the cavity. This attachment feature mayallow the user to thread in a twisting motion the example cap deviceonto a surface such as a male LUER-LOK® connector, for example. FIG. 1also illustrates cap device 100 having a flange 104 along the bottomsurface (the bottom surface/end of cap device 100 designated with arrow106 and the top surface/end of cap device designated with arrow 108) ofthe opening and extending away from the opening of the cap device. Insome embodiments, the flange 104 may allow cap device 100 to secure to asurface such a female LUER-LOK® connector, for example.

FIG. 2 illustrates an example cap device 200 having a stepped innersurface, including a first inner surface 202 and a second inner surface204, the second inner surface 204 having a smaller average diameter thanthe first inner surface. The first and second inner surfaces 202 and 204may have diameters chosen to match outer diameter (“OD”) of commonmedical equipment connectors on the market (i.e., LUER-LOK®), of maximumand minimum ODs of medical equipment connectors on the market, or basedon other criteria. Further both of the first and second inner surfaces202 and 204 may be tapered (i.e., have a draft angle θ), such that adiameter of the first and second inner surfaces is largest closest to anopening of the example cap device 200 and decreases toward the top,closed end of the example cap device 200. A draft angle of the firstinner surface 202 may be the same as, greater than, or less than a draftangle of the second inner surface 204. When the example cap device 200is placed on a surface of a medical connector, the example cap device200 will slide over the surface until an OD of the surface contacts andseals against the interior surface of the example cap device 200 ateither the first inner diameter 202 (in the case of a connector surfacewith a relatively large OD) or the second inner diameter 204 (in thecase of a connector surface with a relatively small OD).

FIGS. 3 and 4 illustrate alternative embodiments of slip fit cap devices300 and 400, respectively, which have continuous, smooth inner surfaces.Rather than being stepped as in the embodiment of FIG. 2, the protectivecap devices 300 and 400 have continuous, smooth inner surfaces. Theinner surfaces of the cap devices 300 and 400 are tapered to accommodateconnector surfaces of varying OD. However, in order to accommodateconnector surfaces having a wide range of ODs, the draft angle Θ of thecap devices needs to be larger (i.e., a more pronounced taper) as in thecase of protective cap device 300, and/or the protective cap deviceneeds to be made deeper, as in the case of protective cap device 400.

In some embodiments, each of example cap devices 100, 200, 300, and/or400 may be constructed with a flange on the inner surface at the openingof a cavity of the cap device. In this embodiment, the inner surface ofthe example cap device may otherwise have a continuous smooth surface.Furthermore, the size of the flange may vary depending, in part, on theOD of the connector surface to be attached to the cap device. When theexample cap device in this embodiment is placed over the connectorsurface the flange allows the example cap device to snap into place overthe connector surface.

FIGS. 5-7 illustrate example embodiments of individually sealedapplicators or cap devices which may form a dual cap device. In eachexample illustrated in FIGS. 5-7, a first applicator or cap device maybe housed in a cavity of a second applicator or cap device. FIG. 5-7illustrated specific applicators cap devices as described above withreference to FIGS. 1-4; however, it should be noted that FIGS. 5-7 arenot limited to the specifically illustrated applicators or cap devices.For instance, any combination of the applicators and cap devicesdescribed above may be used in conjunction with the example embodimentsof individually sealed applicators or cap devices to form a dual capdevices as discussed with reference to FIGS. 5-7.

FIG. 5 illustrates a first cap device 500 which may be removably storedwithin a cavity 502 of a second cap device 504. In some embodiments, thecavity 502 of the second cap 504 may be sealed by a removable protectivefilm 506. The removable protective film 506, while in place over thecavity 502, may prevent the first cap device 500 and other contents suchas an applicator material or antimicrobial composition from escaping. Insome embodiments, the removable protective film 506 may be sealed arounda periphery of the cavity 502 of the second cap device 504 by, forexample, an adhesive (e.g., silicone, silicone rubber, synthetic resin,methyl methacrylate, for example), a thermoplastic, sonic welding,microwave welding, thermal bonding, induction heating, or the like. Insome embodiments, the protective film 506 may be a gas/liquidimpermeable, pore-free (i.e., thicker than 1 micron), flexible materialsuch as aluminum oxide, silicon oxide, or the like.

FIG. 5 illustrates one example embodiment in which both the first capdevice 500 and second cap device 504 include an applicator material 508and 510, respectively, disposed within a cavity of each cap device, sucha cavity 502 of second cap device 504. Applicator material 508 and 510(or any other described herein) may be an open-celled, permeable foam orsponge material, that may be coated or impregnated with a cleansing,antimicrobial, or antiseptic composition such as those described in thepreceding section. Example materials for the composition of theapplicator material 508 and 510 may include, but are not limited tostarch polymer, cellulosic gel, polyurethane, silicon, silicon rubber,polyethylene, polypropylene, thermoplastic elastomer or mixturesthereof. In some embodiments, when the first cap device 500 is storedwithin the second cap device 504, the applicator material 508 may be ina state of compression. In some embodiments, the applicator material 508may expand and/or protrude from the interior cavity of the first capdevice 500 for use in cleaning or disinfecting a desired site surface(e.g., for disinfecting a intravascular port line, site preparation fora medical procedure, or the like). In some embodiments, the applicatormaterial may include a closed-cell region on one or both axial ends ofthe applicator material. In some embodiments, the closed-cell region mayhave different surface finishes, treatments, or contours (e.g., macro-,micro-, or nano-structures, etc.) to facilitate gripping and/orscrubbing of a surface.

In some embodiments, the applicator material 510 housed within cavity502 of the second cap device 504 may include an opening 512 to securethe first cap device 500. In some embodiments, opening 512 may be adiameter smaller than the outer diameter of the first cap device 500.While opening 512 is illustrated as generally circular, the opening 512may be any suitable shape to secure or hold a first cap device of anysize or shape. For example, opening 512 may be a polygon. Furthermore,in some embodiments, the opening 512 may be configured as a cone wherethe diameter of base of cone, which may be positioned toward theexternal portion of the application material 510, is slightly smallerthan a diameter of the first cap device 500 and the diameter of the conetapers toward the apex of the cone, which may be positioned toward theinternal portion of the application material 510.

In some embodiments, the applicator material 508 and/or 510 may include,but are not limited to, different surface treatments (e.g., siping,slitting, etc.), surface finishes (e.g., macro-, micro-, ornano-structures, etc.), and/or contours (e.g., rounded, ribbed,protrusions, fingers, etc.) to provide cleaning and/or scrubbingeffectiveness. In some embodiments, applicator material 508 in the firstcap device 500 may be configured similar to the applicator material 510in the second cap device 504 (e.g., with the same surface treatments,finishes and/or contours). However, in other embodiments, the applicatormaterial 508 in the first cap device 500 may be configured with adifferent surface treatments, finishes and/or contours than theapplicator material 510 in the second cap 504.

In some embodiments, each cap device 500 and 504 may be individuallysealed by a removable protective film or cover over a cavity thatmaintains the applicator material 508 and 510, respectively, and acleansing, antimicrobial, or antiseptic composition in the respectivecap device. In some embodiments, each applicator material 508 and 510 ofeach cap device may contain a different cleansing, antimicrobial orantiseptic composition and/or different concentration of suchcomposition.

FIG. 5 illustrates the applicator material 508 of the first cap device500 may protrude from the cavity of the cap device, while the applicatormaterial 510 of the second cap device 504 fits completely within and/oris recessed in a cavity 502 in the cap device when in use. In that case,the first cap device 500 with the protruding applicator material 508 maybe used to clean a surface (e.g., an intravascular line, valve, or port,an injection site, or the like) and the second cap device 504 with therecessed applicator material 510 may be used to connect to and protectan port, vial, syringe, or other component (e.g., an intravascular lineport, a catheter, or the like).

In some embodiments, where the first cap device or second cap device maybe configured to connect to and/or protect a surface as described above,each of the first and second cap devices may have one of various examplemechanisms for attaching each cap to the surface as described above inFIGS. 1-4.

FIG. 6 illustrates another example embodiment in which a first capdevice 600 may be removably stored within a cavity 602 of a second capdevice 604. FIG. 6 illustrates the first cap device 600 and the secondcap device 604 similar to the cap device illustrated in FIGS. 3 and 4,respectively. However, the first cap device and the second cap devicemay be any combination of the cap devices described above with regard toFIGS. 1-4.

As shown in FIG. 6, the first cap device 600 may include an applicatormaterial 606 within a cavity of the first cap device. Details of theapplicator material are discussed above with regard to FIG. 5. In someembodiments, both, neither, or any combination thereof of the first capdevice 600 and the second cap device may have an applicator material. Insome embodiments, the applicator material may be coated or saturatedwith a composition such as an antimicrobial solution.

In some embodiments, the first cap device 600 may be sealed with aprotective film 608. Details of the protective film are discussed abovewith regard to FIG. 5. In some embodiments, the protective film 608 maycreate a liquid and/or gas impermeable barrier to contain the applicatormaterial 606 and/or any composition within the cavity of the first capdevice 600.

In some embodiments, the individually sealed first cap device 600 may beconfigured to fit within the second cap device 600 such that the firstcap device is completely within the cavity 602 of the second cap device604. In other embodiments, the first cap device 600 may be configured topartially fill the cavity 602 of the second cap device 604.

In some embodiments, the cavity 602 of the second cap device 604 may betreated or coated with a composition such as an antimicrobial solution.In some embodiments, the cavity 602 of the second cap device 604 mayinclude an applicator material which may be coated or saturated with acomposition such as an antimicrobial solution.

FIG. 6 illustrates a second protective film 610 which may be removablyattached to the flange of the second cap device 604. In someembodiments, the second protective film 610 may create a barrier holdingthe individually sealed first cap device 600 within the cavity 602 ofthe second cap device 604. In some embodiments, the protective film 608on the first cap device 600 and the second protective film 610 on thesecond cap device 604 may be composed of the same material. However, inother embodiments, the protective films 608 and 610 may be composed ofdifferent material depending on the contents (i.e., applicator material,composition, other caps) of the cavity of the respective cavities of thecap devices and/or the type of mechanism of sealing the protective film(i.e., sonic welding, microwave welding, thermal bonding, or the like).

In some embodiments, the protective film 610 may be removed from thesecond cap device 604 to expose the cavity 602. Within the cavity 602,may be the first cap device 600 individually sealed with the protectivefilm 608. In some embodiments, the first cap device 600 may be removedfrom the cavity 602 of the second cap device 604. In some embodiments,the first cap device 600 and/or the second cap device 604 (which mayinclude an applicator material (not shown)) may then be used to cleanand/or protect a surface such as a port, vial, syringe, or othercomponent (e.g., an intravascular line port, a catheter, or the like).In some embodiments, the first cap device 600 and/or second cap device604 may securely attach to the surface. In some embodiments, the firstcap device 600 may be used to clean the surface while the second capdevice 604 may subsequently be placed over the surface to protect thesurface from recontamination.

In some embodiments, the protective film 608 may be removed from thefirst cap device 600 to expose the applicator material 606 and/orcompositions therein. The first cap device 600 may then be used to cleanand/or protect a surface such as a port, vial, syringe, an injectionsite, or other component (e.g., an intravascular line port, a catheter,or the like). In some embodiments, the first cap device 600 may securelyattach to the surface.

FIG. 7 illustrates another example embodiment in which a first capdevice 700 may be removably stored within a cavity 702 of a second capdevice 704. FIG. 7 illustrates the second cap device 704 similar to thecap device illustrated in FIG. 3. However, the first cap device 700 andthe second cap device 704 may be any combination of the cap devicesdescribed above with regard to FIGS. 1-4.

As shown in FIG. 7, the first cap device 700 may be configured to fitinto the cavity 702 of the second cap device 704 while the protectivefilm 706 may removably seal to the flange of the second cap device 704to secure the first cap device 700 within at least a part of the cavity702. In some embodiments, a cavity of the first cap device 700 and/orcavity 702 of the second cap device 704 may have an applicator materialand/or composition as described above. In some embodiments, the firstcap device 700 may also include a protective film over the cavity whilesecured in the cavity 702 of the second device 704.

FIG. 8 illustrates an example configuration and packaging ofindividually sealed applicators and cap devices. As illustrated,individually sealed cap devices 800(1)-(4) are attached to a substrate(e.g., a strip or a sheet of material) 802 at an end opposite the endsealed by protective film 804(1)-(4), respectively. In some embodiments,any number of cap devices may be attached to the substrate 802. Forexample, the substrate 802 may include two cap devices or 100 capdevices. In some embodiments, the individually sealed cap devices800(1)-(4) may be single cap devices as shown and described in referenceto FIGS. 1-4. In other embodiments, the individually sealed cap devices800(1)-(4) may include the individually sealed dual cap devices shownand described with reference to FIGS. 5-7. In some embodiments, theindividually sealed cap devices 800(1)-(4) on the substrate 802 may bethe same cap devices (i.e., all single cap devices); however, in someembodiments, the individually sealed cap devices 800(1)-(4) on thesubstrate 802 may be a combination of different cap devices (i.e., oneor more single cap devices and one or more dual cap devices).

While FIG. 8 illustrates the cap devices in a single row, otherembodiments may include two or more cap devices in a row across thesubstrate 802. In some embodiments, each cap device 800(1)-(4) may beattached to substrate 802 on a cap device surface other than the endopposite a cavity end sealed by protective film 804(1)-(4). Forinstance, each of the individually sealed cap devices 800(1)-(4) may beattached to the substrate 802 by a side surface of the cap devices800(1)-(4). In some embodiments, each individually sealed cap device800(1)-(4) may be attached to substrate 802 by an adhesive, sonicwelding, microwave welding, thermal bonding, or the like.

In some embodiments, the substrate 802 may be composed of a flexible,rollable thermoplastic material. Individually sealed cap devices maythen by dispensed by cutting between the cap devices 800(1)-(4) in thesubstrate 802. Alternatively, the substrate 802 may include perforationsor score lines between the individually sealed cap devices in thesubstrate 802.

In other embodiments, the individually sealed cap device 800(1)-(4) maybe attached to the substrate 802 by an end of the opening covered by theprotective film 804(1)-(4). For instance, each protective film804(1)-(4) may be bonded to the substrate 802 such that each cap device800(1)-(4) may be peeled away or otherwise removed from the substrate802 while the protective film 804(1)-(4) remains on each respective cap.

FIG. 9 illustrates another example embodiment in which first cap devices900(1)-(4) may be removably stored within a cavity 902(1)-(4) of secondcap devices 904(1)-(4), respectively, and sealed with protective films906(1)-(4), respectively, to create a dual cap device 910(1). FIG. 9further illustrates each individually sealed dual cap device may beattached to a substrate 908.

In some embodiments, both of the first cap devices 900(1)-(4) and thesecond cap devices 904(1)-(4) may include an applications materialand/or a composition. In some embodiments, both of the first cap devices900(1)-(4) and the second cap devices 904(1)-(4) may include aprotective film to prevent contamination of the cavity of eachrespective cap device when sealed.

In some embodiments, the individually sealed dual cap device 910(1) maybe removed from the substrate 908. In some embodiments, the protectivefilm 906(1) may be removed from the second cap device 904(1) to exposethe cavity 902(1) which secures the first cap device 900(1). In someembodiments, the cavity 912 of the first cap device may be secured to afirst surface (e.g., female LUER-LOK® connector of an intravascular lineport, a catheter, or the like) by manipulating an exterior surface ofthe second cap device 904(1) while the first cap device 900(1) is in thecavity 902(1). Upon the first cap device 900(1) being secured to thefirst surface, the cavity 902(1) may release the first cap device900(1). In some embodiments, the second cap device 904(1) may then beused to clean and/or protect a second, different surface such as a port,vial, syringe, an injection site, or other component (e.g., maleLUER-LOK® connector of an intravascular line port, a catheter, or thelike). In some embodiments, the second cap device 904(1) may securelyattach to the second, different surface.

Conclusion

Although the disclosure describes embodiments having specific structuralfeatures and/or methodological acts, it is to be understood that theclaims are not necessarily limited to the specific features or actsdescribed. Rather, the specific features and acts are merelyillustrative some embodiments that fall within the scope of the claimsof the disclosure.

What is claimed is:
 1. An apparatus comprising: a plurality of caps,each cap having an opening and a cavity, and each cap including a filmreleasably attached to the respective cap adjacent the opening to sealthe cavity; and a substrate to which each cap is releasably attachedconsecutively via an external surface of a closed end of the respectivecap opposite the film at the opening sealing the cavity such that eachcap is individually removable from the substrate without separating thefilm from the opening, the substrate, when the plurality of caps are andare not attached to the substrate, being a flexible and rollable strip,and the plurality of caps being disposed in a row along a length of therollable strip.
 2. The apparatus as recited in claim 1, wherein thecavity contains applicator material permeated with a cleansing,antiseptic or antimicrobial agent.
 3. The apparatus as recited in claim2, wherein the cleansing, antiseptic or antimicrobial agent comprises asurfactant, water, an alcohol, a peroxide or peroxide-generating agent,and a chelating agent.
 4. The apparatus as recited in claim 1, whereinthe substrate comprises a thermoplastic material.
 5. The apparatus asrecited in claim 1, wherein a surface structure of walls of the cavityis formed with one of a tapered stepped surface, a tapered smoothsurface, a stepped surface, or threads.
 6. An apparatus comprising: aplurality of medical cap devices, each medical cap device having acavity defined by an opening at a bottom end and a closed top endopposite the opening at the bottom end, a protective film secured to thebottom end securing an applicator material containing a cleansing,antiseptic or antimicrobial agent within the cavity; and a substrate towhich each medical cap device is removably adhered via an externalsurface of the closed top end opposite the film such that each medicalcap device is individually removable from the substrate withoutseparating the film from the bottom end, the substrate, when theplurality of caps are and are not attached to the substrate, being aflexible and rollable strip, and the plurality of medical cap devicesbeing disposed in a row along a length of the rollable strip.
 7. Theapparatus as recited in claim 6, wherein the substrate comprises athermoplastic material.
 8. The apparatus as recited in claim 6, whereinthe protective film comprises a gas impermeable, liquid impermeable,pore-free material.
 9. The apparatus as recited in claim 6, wherein thecleansing, antiseptic or antimicrobial agent comprises: about 5 to about50 mg/ml of ethylenediaminetetraacetic acid (EDTA); at most about 70%ethanol, by volume; at most about 7.5% hydrogen peroxide, by volume; andwater.
 10. A method of manufacturing a device, the method comprising:attaching a plurality of caps consecutively in a row to a flexible,rollable substrate strip, each cap having an opening and a cavity, andeach cap being releasably attached to the rollable substrate strip viaan external surface of a closed end opposite the opening of eachrespective cap; and attaching a respective removable film to eachrespective cap adjacent the opening to seal the cavity, wherein each capis individually removable from the substrate strip without separatingthe film from the opening and the flexible, rollable substrate strip isrollable when the plurality of caps are and are not attached to thesubstrate.
 11. The method as recited in claim 10, wherein the cavitycontains an applicator material permeated with a cleansing, antisepticor antimicrobial agent.
 12. The method as recited in claim 11, whereinthe cleansing, antiseptic or antimicrobial agent comprises a surfactant,water, an alcohol, a peroxide or peroxide-generating agent, and achelating agent.
 13. The method as recited in claim 10, wherein thecavity contains a cleansing, antiseptic or antimicrobial agent in a gelform.
 14. The method as recited in claim 10, wherein the substratecomprises a thermoplastic material.
 15. The method as recited in claim10, wherein a surface structure of walls of the cavity is formed withone of a tapered stepped surface, a tapered smooth surface, a steppedsurface, or threads.